Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
Study NCT ID:
NCT04541966
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2020-09-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
What Happens to First Trimester Nuchal Translucency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancies without ultrasound or genetic abnormalities', 'timeFrame': 'immediate antenatal and postnatal period', 'description': 'Pregnancies without ultrasound or genetic abnormalities'}], 'secondaryOutcomes': [{'measure': 'ACPA interest', 'timeFrame': 'immediate antenatal and postnatal period', 'description': 'ACPA interest'}, {'measure': 'percentage of samples for high risk combined for trisomy 21', 'timeFrame': 'immediate antenatal and postnatal period', 'description': 'percentage of samples for high risk combined for trisomy 21'}, {'measure': 'Pregnancy outcomes', 'timeFrame': 'immediate antenatal and postnatal period', 'description': 'Pregnancy outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound abnormalities', 'Genetic abnormalities'], 'conditions': ['Nuchal Translucency']}, 'descriptionModule': {'briefSummary': 'First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. The majority of centers use the 3.5 mm cutoff as the 99th percentile instead of using nuchal translucency based on LCC. The objective of this study is to compare the fate of nuchal hyperclites\\> = 99th p but \\<3.5mm versus 3.5mm. For this the investigators have studied the ultrasound and genetic abnormalities. The investigators were also interested in the pregnancy outcomes and the percentage of pregnancies in the group\\> = 99th p and \\<3.5mm that would have been sampled for a high combined risk for trisomy 21, and therefore to determine the benefit of a systematic sample. for HCN as well as the interest of performing an ACPA that would not be performed on a sample with a high risk of trisomy 21.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Single pregnancies with nuchal hyperclarity in the first trimester\\> = 99th percentile at the Montpellier University Hospital with early pregnancy between January 2017 and December 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nnuchal translucency\\> = 99th percentile\n\nExclusion criteria:\n\n\\- multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT04541966', 'briefTitle': 'What Happens to First Trimester Nuchal Translucency', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'What Happens to First Trimester Nuchal Translucency Greater Than or Equal 99ème Percentile and Inferior 3.5 mm', 'orgStudyIdInfo': {'id': 'RECHMPL20_0479'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nuchal translucency> = 99th percentile and <3.5mm', 'description': 'Nuchal translucency\\> = 99th percentile and \\<3.5mm'}, {'label': 'Nuchal translucency> = 3.5 mm', 'description': 'Nuchal translucency\\> = 3.5 mm'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Florent FUCHS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}